Label: PAIN RELIEVING ARTHRITIS- histamine dihydrochloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 1, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Histamine dihydrochloride ...... 0.025%

  • Purpose

    External Analgesic

  • Uses

    • For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains & bruises.
  • Warnings

    • For external use only.
    • Do not use on wounds or damaged skin or if you are allergic to ingredients in the product.
  • When using this product

    • avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.
    • do not bandage tightly or use a heating pad.
  • Stop use and ask a doctor if

    • rash appears.
    • condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.
  • If pregnant or breast feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • For Use by Adults and Children over 12 years.
    • Apply a thin layer to pain site and massage until thoroughly absorbed into skin. Apply no more than 3 to 4 times daily.
    • Children 12 years or younger consult a physician.
  • Other information

    • Store between 40°F and 86°F ( 4°C and 30C).
    • Tamper Evident Feature: do not use if outer shrink wrap on jar is torn, broken or missing.
  • Inactive ingredients

    butylated hydroxyl toluene, cetostearyl alcohol , cetomacrogol 1000, cetyl alcohol, disodium EDTA, disodium hydrogen phosphate, light liquid paraffin, propylene glycol, sorbic acid, transquitol P, white petroleum jelly

  • Questions or Comments? Call 1855-314-1850

    Distributed by: Velocity Pharma LLC 
    Farmingdale, NY, 11735

  • PRINCIPAL DISPLAY PANEL

    Pain Relieving Arthritis Cream

    Net Wt. 4 oz (119g) Arthritis Pain Relief Cream

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING ARTHRITIS 
    histamine dihydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.025 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DISODIUM HYDROGEN CITRATE (UNII: 6FO62KCQ7A)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76168-108-45119 g in 1 JAR; Type 0: Not a Combination Product03/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2017
    Labeler - Velocity Pharma LLC (962198409)
    Registrant - Velocity Pharma LLC (962198409)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yash Pharmceuticals871409551manufacture(76168-108)
    Establishment
    NameAddressID/FEIBusiness Operations
    Velocity Pharma LLC962198409label(76168-108)
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